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FDA Authorizes Study of 2 Novel Treatments for Patients With PSMA+ mCRPC
64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA have received FDA authorization for the open-label, single-arm, dose escalation 1/2a SECURE trial to explore 2 novel PSMA theragnostic treatments in patients with metastatic castration-resistant prostate cancer (mCRPC).
Researchers intend to explore PSMA PET imaging through 64Cu-SAR-bisPSMA and will select patients for PSMA targeted therapy in the 67Cu-SAR-bisPSMA trial. Approximately 44 patients will enroll in various sites across the United States.
Eligibility criteria requires patients to have mCRPC progression despite androgen deprivation therapy with at least 1 second-generation androgen receptor pathway inhibitor. Further, patients must have an ECOG performance status of 0 to 2 and a castrate level of serum/plasma testosterone (<50 ng/dL or <1.7 nmol/L).
Primary outcome measures for 64Cu-SAR-bisPSMA involve biodistribution and dosimetry through utilizing PET/CT scans as well as incidences of adverse events (AEs).
As for the 67Cu-SAR-bisPSMA trial, maximum tolerated dose (MTD), efficacy of PSA response and radiographic response, AEs, and safety and tolerability are primary outcome measures. AEs will be assessed by CTCAE version 5.0.
“We are excited to commence the SECURE trial in mCRPC patients and have engaged a world class group of key opinion leaders in the prostate cancer space to support the development of 64/67Cu-SAR-bisPSMA,” concluded the study’s authors. – Alexa Stoia
